Catalog Number

-

Brand Name

NA

Version/Model Number

ARD515031450A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 12, 2022

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K070442

Product Code

FSY

Product Code Name

Light, surgical, ceiling mounted

Public Device Record Key

8db37500-9ed2-4a8e-a63b-e2595a01e33b

Public Version Date

March 30, 2022

Public Version Number

5

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-